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The effect of graduated compression stockings on long-term outcomes after stroke: the CLOTS trials 1 and 2

1, Martin Dennis, Peter Sandercock

  • 1Division of Clinical Neurosciences, University of Edinburgh, Western General Hospital, Crewe Rd, Edinburgh EH4 2XU, UK. martin.dennis@ed.ac.uk

Stroke
|March 14, 2013
PubMed

Insights

Graduated compression stockings did not significantly reduce venous thromboembolism events or improve functional status in stroke patients. Thigh-length stockings showed a nonsignificant increase in mortality risk within six months.

Area of Science:

  • Clinical Medicine
  • Vascular Surgery
  • Neurology

Background:

  • Randomized controlled trials (RCTs) for venous thromboembolism (VTE) prophylaxis primarily focus on deep vein thrombosis (DVT) detection via imaging.
  • Limited evidence exists on the long-term effects of graduated compression stockings (GCS) on VTE events, survival, and functional outcomes post-stroke.

Purpose of the Study:

  • To evaluate the efficacy of GCS in reducing VTE events, improving survival, and enhancing functional status at 6 months following stroke.
  • To assess the impact of thigh-length versus below-knee GCS on these outcomes.

Main Methods:

  • The CLOTS (Compliance with Leg Observation and Treatment Study) Trials employed an international, multicenter, parallel-group design with central randomization (1:1 allocation).
  • CLOTS Trial 1: 2518 immobile stroke patients allocated to thigh-length GCS or no GCS.
  • CLOTS Trial 2: 3014 stroke patients allocated to thigh-length or below-knee GCS. Outcomes measured at 6 months included vital status, Oxford Handicap Scale, and quality of life (EQ5D-3 L).

Main Results:

  • Allocation to thigh-length GCS was associated with a nonsignificant trend towards increased mortality within 6 months in both trials (Trial 1 HR: 1.087; Trial 2 HR: 1.037).
  • No statistically significant differences were observed in VTE events between GCS treatment groups.
  • There were no significant differences in Oxford Handicap Scale or EQ5D-3 L scores between the treatment groups.

Conclusions:

  • The study results effectively exclude a greater than 10% relative reduction in 6-month mortality risk associated with thigh-length GCS.
  • No significant long-term benefits in terms of VTE events or functional status were demonstrated with GCS use post-stroke.
  • While underpowered for detecting clinically significant long-term effects, the findings suggest GCS may not offer substantial benefits for these outcomes in stroke patients.
Abstract

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